Sensory Awareness Program

February 4, 2026 updated by: Lund University

Coping Through Sensory Modulation. A Sensory Awareness Program (SAP) for Reducing Anxiety and Mobilizing Coping Strategies for People With Severe Mental Health Problems. A Randomized Controlled Trial.

Few alternatives to addictive medical treatment exists for persons with severe mental health problems (SMHP) and anxiety, often connected to high risk of suicide. Access to effective interventions that depart in individuals' needs to cope with anxiety in everyday life is crucial to provide and desperately warranted by service users. Service users are often unaware of sensory needs, connected to anxiety outburst. The Sensory Awareness Program (SAP) is a group-based self-management intervention of 10 weeks developed to meet complex needs of regulating anxiety and related self-destructive behaviors. SAP stems from theories on sensory modulation and is an approach to manage physiological arousal associated with anxiety through self-regulated sensory-based coping strategies. International research show that sensory modulation is effective both as a method to reduce anxiety and thus restraint in acute mental health services (MHS), and also to empower users. However, much research to date focus on using sensory strategies within wards. International research and pre-studies of testing the SAP in outpatient MHS indicate that it is a promising self-management intervention to support everyday life. Earlier studies further show that users' unawareness of sensory needs triggers anxiety, and that anxiety itself is the main contributing factor for disrupting everyday life. Also, staff acknowledge sensory modulation but lack knowledge on whether programs such as SAP is effective and possible to implement.

The overall aim is to investigate the effectiveness of SAP as compared to treatment as usual (TAU) among 200 outpatients. The investigators hypothesize that SAP will be more effective than TAU in terms of reduced anxiety (primary outcome) at three months follow-up. Secondary clinical and personal recovery outcomes post intervention and at three and six months follow up will also be targeted and assumed to be in favour of the SAP group. The implementation process of the SAP will also be explored.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Helsingborg, Sweden
        • Region Skane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be assigned to a MHS
  • Age over 18
  • Having SMHP (including a diagnosis of mood disorder, anxiety disorder, eg PTSD, panic disorder etc, and/or psychotic disorder)
  • Experience anxiety

Exclusion Criteria:

  • Acutely mentally unwell
  • Cognitively impaired
  • Non-Swedish speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment as usual
Other: Treatment as usual (TAU)
Treatment as usual is standard psychiatric care for the target group.
Experimental: Sensory Awareness Program
Behavioral: Sensory Awareness Program (SAP)
SAP is a new rehabilitation program for people with severe mental health problems. SAP aims to help the target group manage anxiety outburst and live an active life through sensory modulation techniques.
Other: Treatment as usual (TAU)
Treatment as usual is standard psychiatric care for the target group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Becks anxiety inventory (BAI)
Time Frame: Before intervention, post intervention (at 3 months), 6 and 9 months
The Beck Anxiety Inventory (BAI) is a self-report questionnaire measuring the severity of anxiety symptoms with 21 questions, each describing a symptom of anxiety. The participant rates each item on a scale from 0 to 3, indicating how much he/she experiences each symptom. The scores range from 0 to 63, with higher scores indicating more severe levels of anxiety.
Before intervention, post intervention (at 3 months), 6 and 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hopkins Symptom Checklist-25 (HSCL-25)
Time Frame: Before intervention, post intervention (at 3 months), 6 and 9 months
The Hopkins Symptoms Checklist (HSCL-25) is a widely used screening instrument with 25 items measuring symptoms of anxiety and depression. The scale for each question includes four response categories from 1 (not at all) to 4 (very much). The total score is the average of all 25 items.
Before intervention, post intervention (at 3 months), 6 and 9 months
Difficulties in Emotion Regulation scale (DERS)
Time Frame: Before intervention, post intervention (at 3 months), 6 and 9 months
The Difficulties in Emotion Regulation Scale (DERS) is a self-report measure of emotion regulation difficulties. The total score ranges from 16-80 with higher scores indicating more difficulties with emotion regulation.
Before intervention, post intervention (at 3 months), 6 and 9 months
Coping Orientation of Problem Experience Inventory (COPE)
Time Frame: Before intervention, post intervention (at 3 months), 6 and 9 months
The Brief-COPE is an instrument reflecting individuals' coping strategies when exposed to a stressful situation. Brief-COPE is the short version and consists of 14 sub-scales, with 2 items in each scale, with a total of 28 items. The items are rated on a scale from 1 (seldom) to 4 (very often). In the current study, we will use the three-factor model of the instrument where the 14 subscales are divided into 3 factors; 'Problem-focused coping', 'Emotion-focused coping' and 'Avoidant coping'.
Before intervention, post intervention (at 3 months), 6 and 9 months
Manchester Short Assessment of Quality of Life Scale (MANSA)
Time Frame: Before intervention, post intervention (at 3 months), 6 and 9 months
The Manchester Short Assessment of Quality of Life (MANSA) consists of 16 questions, covering different domains of life such as physical health, social relationships, employment, and overall life satisfaction. Each question is rated on a scale from 1 to 7, with higher scores indicating better quality of life.
Before intervention, post intervention (at 3 months), 6 and 9 months
Pearlin Mastery Scale
Time Frame: Before intervention, post intervention (at 3 months), 6 and 9 months
The Pearlin Mastery Scale is used to assess an individual's perceived sense of control over their life circumstances, containing seven questions to rate the level of agreement with statements about the ability to control and influence life. It covers areas such as personal growth, problem-solving, and self-mastery and is rated on a scale from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating greater levels of mastery.
Before intervention, post intervention (at 3 months), 6 and 9 months
Process of Recovery Questionnaire (QPR-7)
Time Frame: Before intervention, post intervention (at 3 months), 6 and 9 months
The Process of Recovery Questionnaire (QPR-7) is a short version of the instrument with 15 items (Argentzell et al., 2017). QPR-7 has seven questions concerning which aspects of recovery have been meaningful for the participants on a five-graded scale from 0 (disagree strongly) to 4 (agree strongly).
Before intervention, post intervention (at 3 months), 6 and 9 months
Profiles of Occupationa Engagement (POES)
Time Frame: Before intervention, post intervention (at 3 months), 6 and 9 months
POES is an instrument that helps to discern the level of occupational engagement. The POES has two parts, one being the 24-hour yesterday time use diary and a second part consisting of a self-rated questionnaire with 9 items representing different components of occupational engagement. Based on the time diary the participants reflect on the content and rate to what extent it corresponds to a lower or higher level of occupational engagement on a 4-point scale.
Before intervention, post intervention (at 3 months), 6 and 9 months
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time Frame: Before intervention, post intervention (at 3 months), 6 and 9 months
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a questionnaire used to assess an individual's perceived level of functioning and disability across six domains of life with 12 questions covering: activities and participation in society. Each question is rated on a scale from 0 to 4, with higher scores reflecting greater levels of disability.
Before intervention, post intervention (at 3 months), 6 and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

March 2, 2025

Study Completion (Actual)

March 2, 2025

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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